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Completed Phase 3 Interventional Results available

Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease

ClinicalTrials.gov ID: NCT03425539

Public ClinicalTrials.gov record NCT03425539. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, dOuble-blind, ranDomized, Placebo-controlled, Parallel-group Study to Determine the effIcacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With FabrY Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease.

Study identification

NCT ID
NCT03425539
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Industry
Enrollment
118 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 20, 2018
Primary completion
Aug 16, 2021
Completion
Sep 1, 2021
Last update posted
Aug 8, 2024

2018 – 2021

United States locations

U.S. sites
17
U.S. states
15
U.S. cities
17
Facility City State ZIP Site status
University of Alabama at Birmingham - Nephrology Research Clinic Birmingham Alabama 35233
University of California Irvine Irvine California 92696
UCSF Benioff Children's Hospital Oakland Oakland California 94609
University of Florida College of Medicine - Division of Nephrology, Hypertension & Renal Transplantation Gainesville Florida 32610
Emory University School of Medicine; Department of Human Genetics Atlanta Georgia 30322
Rush University Medical Center Chicago Illinois 60612
University of Iowa Stead Family Children's Hospital - Division of Medical Genetics Iowa City Iowa 52242
Massachusetts General Hospital Boston Massachusetts 02114
Infusion Associates Grand Rapids Michigan 49525
Duke University Medical Center Durham North Carolina 27710
Oregon Health and Science University Portland Oregon 97239
University of Pennsylvania Philadelphia Pennsylvania 19104
Children's Hospital of Pittsburgh (UPMC) Pittsburgh Pennsylvania 15224
Greenwood Genetic Center Greenville South Carolina 29605
Research Baylor Institute of Metabolic Disease Dallas Texas 75226
University of Utah - Division of Medical Genetics Salt Lake City Utah 84113
Lysosomal and Rare Disorders Research and Treatment Center Fairfax Virginia 22030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03425539, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 8, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03425539 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →